BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA

    K Number: K851377 · Decision Aug 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    135

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    Basic Information

    Device Name
    DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
    K Number
    K851377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnon Corp.
    Date Received
    April 8, 1985
    Decision Date
    August 21, 1985
    Product Code
    CDD
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CDD Radioassay, Vitamin B12

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    Other Clearances by Diagnon Corp.

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